This FDA Inspection process training will discuss how to prepare for the inspection, what to do during the inspection and the close-out interview, and how to respond to the inspection.
Does the FDA call in advance or just show up at my door? Where do I let the inspector go? Do I give them a tour? What should I let them see? Who should I let them talk to? Are they ever going to leave?
The FDA inspection is the most nerve-wracking event in the life of a regulatory professional – you are in charge of compliance, usually in the background and now you are in the spotlight and if your performance isn’t good, it’s not the show that may close, it’s your company! However, adequate planning, training, composure, and understanding should result in many encore presentations! This session will be the limits of FDA’s scope during an inspection, including what documents you are not required to show them, and the permissibility of photographs and affidavits.
- How to prepare for an FDA inspection
- Development and contents of an SOP for FDA inspection
- Personnel training before inspection
- How to behave during an inspection
- Limitations of the scope of an inspection
- Response to investigation findings
- FDA guidance documents used by their inspectors
- Quality Assurance Departments
- Quality Control Departments
- Compliance Departments
- Regulatory Affairs Departments
- Engineering Departments
- CAPA Specialists
- Management Representatives
- Consultants and Contractors
- who may have direct interaction with FDA officials